Pulmonary Hypertension of Newborn
Conditions
Brief summary
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.
Interventions
DEVICENitric Oxide Generator and Delivery System
Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.
Sponsors
Novlead Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians 2. Admitted to the Department of Neonatology at the hospital, gender unlimited 3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support 4. Documented Oxygenation index (OI) ≥8 prior to the treatment 5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study
Exclusion criteria
1. Proven risks of nitric oxide contraindication 2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation 3. Other circumstances that investigators believe unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oxygenation Index (OI) | Baseline, Minutes 45 | OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oxygen Saturation | Baseline, Hour 24, 2 hours after iNO is discontinued | Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2) |
| Change From Baseline in Pulmonary Artery Pressure (PAP) | Baseline, Hour 24, 2 hours after iNO is discontinued | Doppler echocardiography is used to detect the regurgitation velocity, and tricuspid regurgitation V values are derived. PAP = 4 × V2 + 5 mmHg. |
| Change From Baseline in Oxygenation Index (OI) | Baseline, Hour 24, 2 hours after iNO is discontinued | OI = MPAW×100×FiO2/PaO2 |
| Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment | Minutes 45, Hour 24, 2 hours after iNO is discontinued | Parameters detected by Nitric Oxide Generator and Delivery System |
| Adverse events | Baseline up to 24 hours after iNO is discontinued | Incidence of adverse events=Number of subjects with adverse events/Total number of subjects in treatment |
| Percentage of subjects responding to iNO | Hour 24, 2 hours after iNO is discontinued | Responding to iNO is defined as a decrease in OI of 25% or more |
Countries
China
Contacts
Primary ContactZhou Fang
Outcome results
None listed